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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUBTROC LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. SUBTROC LAG SCREW DRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674068
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2020
Event Type  malfunction  
Event Description
It was reported that during intertan procedure when planting the subtrochante screw noticed the back of the capture piece was broken on the back. It was outside the patient. The procedure was completed without delay using an smith&nephew backup device. No patient harm or additional complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSUBTROC LAG SCREW DRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10825451
MDR Text Key215874549
Report Number1020279-2020-06389
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71674068
Device Catalogue Number71674068
Device Lot Number09BSP0002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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